Senior Biostatistician (up to $10K in sign on bonus!)

What You'll Do:

• Assist with the development and modification of department SOPs and work instructions • Assist with training new Biostatistics employees; mentor and assist junior level biostatisticians • Develop study bids and changes in scope for Biostatistics tasks in response to prospective client's request for proposals (RFPs). • Attend and present the Biostatistics study execution tasks at capabilities presentations. • As the lead Biostatistician on the studies to which you are assigned, perform or oversee the following tasks: • Act as primary statistical contact for internal and external project team members. • Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep Biostatistics management aware of changes to project timelines. • Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management. • Review case report forms (CRFs) and completion instructions • Give input to database design and data edit considerations necessary to collect and clean data • Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol • Develop or review program specifications - SDTM and ADaM dataset specifications and mock tables, listings and figures (TLFs) - needed to perform the analysis defined in the IAP/SAP • Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer's corresponding programs per department SOPs • Review programming of other team members • Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications • Plan and design clinical studies, including: • overall study design development • outcome / endpoint determination • power analysis / sample size estimation reports • randomization and blinding procedures development • statistical methods section development in the protocol • Develop or review Randomization Plans and randomization programs or lists • Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines • Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers • Maintain accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan • Provide input to and participate in departmental meetings

What You'll Bring

• 7+ years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience • Master's degree in Biostatistics, Statistics or related field • CDISC SDTM and ADaM dataset mapping experience